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Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer (NIVOFGFR2)

Primary Purpose

Metastatic Gastric Cancer, PD-L1 Gene Amplification, FGFR2 Amplification

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Capecitabine
Oxaliplatin
Sponsored by
Kidney Cancer Research Bureau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma Measurable lesions according to the RECIST 1.1 criteria PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells Possibility to assess the amplification of FGFR2 HER2-negative status ECOG PS 0-2 Age >= 18 years old Adequate function of organs Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study Signed Informed Consent Exclusion Criteria: Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease Pregnancy Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C Surgery within 7 days before the first dose of the study drug Signs of bleeding or hemorrhagic diathesis

Sites / Locations

  • Bureau for Cancer ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab in combination with chemotherapy

Arm Description

Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) every 3 weeks

Outcomes

Primary Outcome Measures

1-year progression-free survival (PFS)
Proportion of patients who will be progression-free at 1 year

Secondary Outcome Measures

Median PFS
From first day of treatment to the first observation of disease progression or death due to any cause
Median overall survival (OS)
From first day of treatment to time of death due to any cause.
Objective response rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Toxicity Summary
toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.

Full Information

First Posted
May 1, 2023
Last Updated
May 10, 2023
Sponsor
Kidney Cancer Research Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT05859477
Brief Title
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
Acronym
NIVOFGFR2
Official Title
Nivolumab and CapeOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kidney Cancer Research Bureau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CapeOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
Detailed Description
On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment. Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2. The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastric Cancer, PD-L1 Gene Amplification, FGFR2 Amplification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Nivolumab in combination with chemotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab in combination with chemotherapy
Arm Type
Experimental
Arm Description
Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
360 mg, i.v., every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
30 mg/m², i.v., day 1, every 3 weeks
Primary Outcome Measure Information:
Title
1-year progression-free survival (PFS)
Description
Proportion of patients who will be progression-free at 1 year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Median PFS
Description
From first day of treatment to the first observation of disease progression or death due to any cause
Time Frame
18 months
Title
Median overall survival (OS)
Description
From first day of treatment to time of death due to any cause.
Time Frame
24 months
Title
Objective response rate (ORR)
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
18 months
Title
Toxicity Summary
Description
toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.
Time Frame
Up to 30 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma Measurable lesions according to the RECIST 1.1 criteria PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells Possibility to assess the amplification of FGFR2 HER2-negative status ECOG PS 0-2 Age >= 18 years old Adequate function of organs Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study Signed Informed Consent Exclusion Criteria: Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease Pregnancy Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C Surgery within 7 days before the first dose of the study drug Signs of bleeding or hemorrhagic diathesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilya Tsimafeyeu
Phone
+19178914943
Email
director@bucare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Tsimafeyeu
Organizational Affiliation
Bureau for Cancer Research
Official's Role
Study Chair
Facility Information:
Facility Name
Bureau for Cancer Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnolia Rouge
Phone
917-981-6485
Email
bucare@bucare.org

12. IPD Sharing Statement

Learn more about this trial

Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

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